| Device Type ID | 284 |
| Device Name | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| Regulation Description | Lactate Dehydrogenase Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.1440 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CFJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 284 |
| Device | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| Product Code | CFJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Lactate Dehydrogenase Test System. |
| CFR Regulation Number | 862.1440 [🔎] |
| Device Problems | |
|---|---|
High Test Results | 34 |
Device Ingredient Or Reagent Problem | 1 |
Low Test Results | 1 |
False Negative Result | 1 |
| Total Device Problems | 37 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beckman Coulter Inc. | II | May-12-2017 |
| 2 | Medtest Holdings, Inc. | II | May-26-2017 |
| 3 | Roche Diagnostics Operations, Inc. | II | Jun-27-2015 |
| 4 | Siemens Healthcare Diagnostics, Inc. | II | Nov-27-2018 |
| 5 | Siemens Healthcare Diagnostics, Inc. | II | May-11-2016 |